Paroxysmal Nocturnal Hemoglobinuria Treatment Advances with Comprehensive Danicopan Market Forecast to 2032
January 24, 2024 10:44 ET
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Research and Markets
Dublin, Jan. 24, 2024 (GLOBE NEWSWIRE) -- The "Danicopan Emerging Drug Insight and Market Forecast - 2032" report has been added to ResearchAndMarkets.com's offering. The global healthcare...
BioNTech und DualityBio erhalten Breakthrough-Therapy-Status der FDA für ADC-Kandidaten BNT323/DB-1303 zur Behandlung von Gebärmutterkrebs
December 21, 2023 08:00 ET
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BioNTech SE
Breakthrough-Therapy-Status basiert auf Phase-1/2-Daten zur Sicherheit und Wirksamkeit in Patientinnen mit Human Epidermal Growth Factor Receptor 2 („HER2“) -exprimierendem, fortgeschrittenen...
BioNTech and DualityBio Receive FDA Breakthrough Therapy Designation for Antibody-Drug Conjugate Candidate BNT323/DB-1303 in Endometrial Cancer
December 21, 2023 08:00 ET
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BioNTech SE
Designation is based on Phase 1/2 safety and efficacy data in patients with Human Epidermal Growth Factor Receptor 2 (“HER2”)-expressing advanced endometrial cancer with encouraging early signs of...
Palvella Therapeutics Announces U.S. FDA Breakthrough Therapy Designation Granted to QTORIN™ 3.9% Rapamycin Anhydrous Gel (QTORIN™ rapamycin) for the Treatment of Microcystic Lymphatic Malformations
November 16, 2023 07:45 ET
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Palvella Therapeutics
QTORIN™ rapamycin has potential to be first approved therapy and standard of care in the U.S. for Microcystic Lymphatic Malformations Microcystic Lymphatic Malformations is a chronically...
Global Pharmaceutical Regulatory Affairs Industry Analysis Report 2023-2030
September 27, 2023 05:33 ET
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Research and Markets
Dublin, Sept. 27, 2023 (GLOBE NEWSWIRE) -- The "Pharmaceutical Regulatory Affairs Market Size, Share & Trends Analysis Report By Services, By Category, By Service Provider, By Company Size, By...
Alkeus Announces $150 Million Series B Financing, Supporting Rapid Registration Path for gildeuretinol (ALK-001) in the Treatment of Stargardt Disease
June 05, 2023 06:00 ET
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Alkeus Pharmaceuticals
CAMBRIDGE, Mass., June 05, 2023 (GLOBE NEWSWIRE) -- Alkeus Pharmaceuticals announced today that it has raised a $150 million Series B financing to support the registration and launch of...
Axsome Therapeutics Initiates ADVANCE-2 Phase 3 Trial of AXS-05 in Alzheimer’s Disease Agitation
September 08, 2022 07:00 ET
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Axsome Therapeutics, Inc.
NEW YORK, Sept. 08, 2022 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing and delivering novel therapies for the management of central nervous...
Junshi Biosciences and Coherus Announce U.S. FDA Breakthrough Therapy Designation Granted for Toripalimab for 1st Line Treatment of Nasopharyngeal Carcinoma
August 12, 2021 08:01 ET
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Coherus BioSciences, Inc.; Junshi Biosciences
SHANGHAI, China, and REDWOOD CITY, Calif., Aug. 12, 2021 (GLOBE NEWSWIRE) -- Shanghai Junshi Biosciences Co., Ltd (“Junshi Biosciences”, HKEX: 1877; SSE: 688180) and Coherus BioSciences, Inc....
FDA Grants Alkeus Pharmaceuticals Breakthrough Therapy Designation for ALK-001 (C20-D3-vitamin A) for the Treatment of Stargardt Disease
July 14, 2021 07:00 ET
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Alkeus Pharmaceuticals
Only drug to receive Breakthrough Therapy Designation for Stargardt DiseaseAlkeus Pharmaceuticals to discuss next steps toward filing an NDA with the FDAOngoing clinical trial of ALK-001 in dry...
Axsome Therapeutics Initiates ACCORD Phase 3 Trial of AXS-05 in Alzheimer’s Disease Agitation
December 31, 2020 06:15 ET
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Axsome Therapeutics, Inc.
ACCORD is the second pivotal trial of AXS-05 in Alzheimer’s disease agitation No treatments are currently approved for Alzheimer’s disease agitation NEW YORK, Dec. 31, 2020 (GLOBE...